Kornimate/medical-research-clean huggingface dataset:
integrated maternal psychosocial assessment to care trial (impact) full trial

Conditions: Anxiety; Depression

Summary: we hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. as such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.

one of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. it is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires. however, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. as such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. cognitive behavioural therapy (cbt) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national australian guidelines as a potentially effective early intervention for reducing the risk of maternal-child outcomes.

Eligibility criteria:
inclusion criteria: pregnant women will be eligible for phase 2 if they are: 1. \< 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery) 2. able to speak/read english; and (3) willing to complete email questionnaires exclusion criteria: 1. \>28 weeks gestation 2. unable to speak/read english 3. unable to complete email questionnaires

Keywords: anxiety depression cbt
transcranial direct current stimulation (tdcs) for the treatment of tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to determine if repeated sessions of transcranial direct current stimulation (tdcs) are effective for treating chronic subjective tinnitus. previous studies have reported brief improvements in tinnitus after safe and noninvasive stimulation of the auditory cortex or limbic system. the investigators hypothesize that a greater improvement in tinnitus will be achieved following repeated sessions of tdcs that target both auditory and limbic systems.

subjective tinnitus is a distressing condition characterized by the sensation of sound or noise in the absence of internal or external stimuli. research indicates that tinnitus may develop due to maladaptive plastic changes in the auditory cortex and limbic system. these changes can be targeted using safe and noninvasive brain stimulation techniques like transcranial direct current stimulation (tdcs). tdcs alters the excitability of the cortex using a weak direct current and may lead to long-term plastic changes, making it a potential therapeutic tool for the treatment of tinnitus. transient improvements in tinnitus have been reported after inhibitory stimulation of the auditory cortex and after excitatory stimulation of the prefrontal cortex, however the effects of a combined stimulation paradigm remain unknown. the investigators hypothesize that a cumulative effect will be observed following repeated sessions of tdcs by modulating both the excitability of the auditory cortex and prefrontal cortex.

Eligibility criteria:
inclusion criteria: * age of at least 18 years * chronic tinnitus for at least 1 year * diagnosis of chronic subjective non-pulsatile tinnitus * age-adjusted normal (sensorineural) hearing * score of 25 or above on the mini-mental state examination (mmse) * must comply with use of contraceptives during interventions exclusion criteria: * objective tinnitus * concurrent treatment for tinnitus * prior exposure to transcranial direct current stimulation (tdcs) * electronic implants or metallic objects in body, including cardiac pacemakers, cochlear implants, implanted medical pump, metal plate in skull, metal implant in the skull or eyes (other than dental appliances or fillings) * skin conditions where electrodes will be applied * major neurological co-morbidities * history of epilepsy and/or seizures * pregnancy and/or lactation

Keywords: tinnitus transcranial direct current stimulation transcranial magnetic stimulation
short term spironolactone for prevention of acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injuries; Kidney Injuries, Acute; Kidney Injury, Acute; Acute Renal Injury; Acute Renal Injuries

Summary: our aim is to test whether short term perioperative administration of oral spironolactone could reduce incidence of postoperative acute kidney injury (aki) in cardiac surgical patients.

adult patients (\>18 years old) were eligible for the study if they were undergoing elective or emergency cardiac surgery requiring cpb and aortic cross clamp. exclusion criteria were patients with preoperative chronic renal insufficiency (serum creatinine \>1.6 mg/dl) or on dialysis, hyperkalemia (\>5.0 meq/l), aki detected up to 24 hours before the procedure; patients receiving contrast agents 72 hours before surgery, planned off-pump cardiac surgery, hypersensitivity, allergy or known intolerance to spironolactone and pregnancy. patients that died during the surgical procedure or 24 hours after surgery were eliminated from the analysis, as well as patients that did not receive spironolactone during the postoperative period. criteria for stopping spironolactone were serum potassium \>5.5 meq/l, a serum creatinine level ≥2.5 mg/dl and urine output of \<0.3 ml/k/hr during 8 hours. one day prior to the procedure, patients that met the inclusion criteria were invited to participate in the trial, signing an informed consent. spironolactone was administered orally by a study investigator (100 mg 12-24 hrs before surgery); subsequently three further doses of 25 mg were administered orally in postoperative days 1, 2 and 3. thus, a total 1 x 100 mg and 3 x 25 mg doses of spironolactone in the intervention group were be given. if the patient had not been extubated, spironolactone was administered nasogastrically. oral drugs were delayed by up to 4 hours if extubation had just occurred. the patients that decided not to receive spironolactone were followed during the study period and considered as controls. preexisting ace inhibitor, angiotensin receptor blocker, or mr antagonist were not suspended before surgery.

Eligibility criteria:
inclusion criteria: * informed consent * elective and emergent cardiac surgery with cardiopulmonary bypass and aortic cross clamp exclusion criteria: * patients with preoperative chronic renal insufficiency on dialysis * acute kidney injury detected up to 24 hours before the procedure a * patients receiving contrast agents 72 hours before surgery * planned off-pump cardiac surgery * hypersensitivity, allergy or known intolerance to spironolactone * pregnancy * hyperkalemia with potassium \>5.0 meq/l criteria for stopping study medication: - serum potassium \>5.5 meq/l

Keywords: acute kidney injury spironolactone
functional connectivity measurement after severe traumatic brain injury

Conditions: Disorder of Consciousness

Summary: to compare functional connectivity after severe traumatic brain injury (tbi) between a group of post-comatose tbi with restored consciousness and a group of post-comatose tbi with persistant disorder of consciousness at admission in rehabilitation

recovery of consciousness can be impaired in severe traumatic brain injury (tbi). prognostic factors are sparse and mostly clinical (mainly the initial glasgow coma scale gcs) (1). functional magnetic resonance imaging (fmri) could allow a better understanding of functional recovery. graph method has been applied to fmri signal analysis in disorder of consciousness (doc) due to post-anoxic encephalopathy. comatose state was characterized by dramatic change in local connectivity (hub location) without significant change in global connectivity (2). the present study aims at describing functional connectivity in doc following severe tbi. we will record resting state fmri in tbi patients in two clinical conditions: conscious state versus doc state.

Eligibility criteria:
inclusion criteria: * severe tbi * no general anesthesia since 7 days * no neuroleptic nor hypnotic drug since 3 days * medical criteria fulfilled to be discharged from icu * medical insurance exclusion criteria: * age \< 18 * contra indication to mri * consent refusal from the family * neurological trouble before tbi * patient protected by law
effectiveness of acupuncture for depressed patients taking antidepressant medications

Conditions: Depression

Summary: in this research study, the investigators piloted a uniform acupuncture treatment protocol among adults with depression who were taking an antidepressant medication that was providing only partial or no symptom alleviation. the study's aims were evaluate the efficacy, safety, and tolerability of acupuncture augmentation treatment among this population. the investigators hypothesized that acupuncture as an augmentation treatment would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). the investigators also hypothesized that acupuncture would be associated with minimal side effects.


Eligibility criteria:
inclusion criteria: * ages 18-65 * a ham-d-17 score of \>= 14 * partial or nonresponse to a standard antidepressant (monotherapy or combination) at an adequate dose over the past 8 or more weeks (natural agents such as omega-3 fatty acids, st john's wort, same, and folic acid, were allowed as antidepressants) * concurrent psychotherapy was allowed, provided that it was not initiated within the 3 months prior to study entry. exclusion criteria: * a primary diagnosis other than major depressive disorder, or any history of psychosis or mania * conditions that could make it difficult to conclusively determine that depressive symptoms were the result of major depression and not some other condition, including any form of substance abuse or dependence within the last 6 months, other medical conditions that could be the basis of a depression (including epilepsy, history of an abnormal eeg, severe head trauma, or stroke) * serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that had not been stable for at least 3 months * having had electroconvulsive therapy (ect) during the past year * current active suicidal or self-injurious potential necessitating immediate treatment.

Keywords: acupuncture antidepressant augmentation depression
study of suramin in subjects with furosemide-resistant aki

Conditions: Acute Kidney Injury

Summary: this is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with aki from progressing to kidney disease improving global outcomes (kdigo) stage iii or dialysis dependent aki.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of signing the informed consent * kdigo stage i aki and a serum cr increase ≥ 0.3 mg/dl within 48 hr or 1.5 to 1.9-times baseline (pre-fst) cr levels within 48 hr (± 6 hr) prior to randomization or kdigo stage ii aki and serum cr increase 2.0 to 2.9-times baseline (pre-fst) cr levels within 48 hr (± 6 hr) prior to randomization * fails to achieve a 200 ml increase in urine output within 2 hr following a 1.0 mg/kg bolus of furosemide (i.e., positive fst) * if female of childbearing potential, must have a negative pregnancy test at screening is capable of providing informed consent as described in in this protocol. exclusion criteria: * receiving hemodialysis or peritoneal dialysis * prior renal transplant (other organ transplants are not excluded) * known baseline (pre-fst) estimated glomerular filtration rate (egfr) ≤ 20 ml/min * evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for subjects without a documented ultrasound, the * investigator will determine if a renal ultrasound is indicated, consistent with the standard of care (soc) * hepatic encephalopathy, child class c cirrhosis, and/or clinical suspicion of hepatorenal syndrome * international normalized ratio (inr) ≤ 3.0, unless on stable long-term warfarin therapy within 2 weeks prior to randomization * known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection * known coronavirus (covid-19) infection * white blood cell count (wbc) \< 2,000/μl and/or platelet count \< 30,000/μl at the time of screening * a sequential organ failure assessment (sofa) score \> 10 during screening * subjects requiring 3 or more vasopressor agents of any combination to maintain a mean arterial pressure \> 65 mm hg * unwilling to participate in follow-up phone surveys up to 180 days post-treatment * are enrolled in another interventional research study or have participated in another interventional study within 14 days of screening.
delinieation of gip's effects during a meal in humans using gip receptor antagonisation (ga-4)

Conditions: Glucose Metabolism Disorders

Summary: delinieation of gip's effects during a meal in humans using gip receptor antagonisation.

aim: to evaluate the role of gipr signalling in postprandial physiology, including lipid, bone and glucose homeostasis, using a naturally occurring gip fragment, which antagonises the gipr. twelve healthy men (age 18-70 years, bmi 19-27 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. study consists of four study days with concomitant infusions of a) gip-a, b) glp-1 receptor antagonist exendin\[9-39\], c) gip-a + exendin\[9-39\], or d) saline (placebo).

Eligibility criteria:
inclusion criteria: * normal kidney function, liver function and hemoglobin levels. exclusion criteria: * medication, diabetes type 1 or 2, bmi \> 27, first degree relatives with type 2 diabetes

Keywords: gip gip receptor antagonist
diabetes nutrition algorithms in patients with overt diabetes mellitus

Conditions: Type 2 Diabetes; NAFLD; Obesity; Dyslipoproteinaemia; Hypertension

Summary: basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. nevertheless, in early and late stage of t2dm, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. the researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term t2dm patients.

basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. nevertheless, in early and late stage of t2dm, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable. the researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term t2dm patients. an intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.

Eligibility criteria:
inclusion criteria: * male and female subjects * 18-79 years old * type 2 diabetes exclusion criteria: * renal insufficiency * anaemia * immunosuppression * previous symptomatic cancer diagnosis * acute cardiovascular disease (stroke, coronary syndrome) * pregnancy and lactation * severe psychiatric disorders * corticoid or other immunosuppressive therapy
plasticity using stimulation and habit: a pilot open-label rtms study for mci

Conditions: Mild Cognitive Impairment

Summary: the goal of this pilot study is to determine whether a high-dose form of non-invasive brain stimulation is a promising and safe treatment for mild cognitive impairment (mci). transcranial magnetic stimulation (tms) is an fda approved treatment for depression. in studies of tms for depression and other disorders, individuals have experienced improved cognitive function. thus, the current study is testing whether tms is safe, feasible and effective in improving cognition in individuals with mci.


Eligibility criteria:
inclusion criteria: * age 60-85 * english as a first/primary language * has been diagnosed with mci by a healthcare provider within the past two years per national institute on aging - alzheimer's association (nia-aa) criteria: (1) concern regarding cognitive decline reported by patient, informant, or clinician, (2) objective evidence of impairment for age in 1+ cognitive domains, typically memory, (3) preserved independent function, (4) no dementia. * has met actuarial neuropsychological criteria for amnestic mci: (1) ≥2 impaired scores (i.e. ≤16th %ile) within one cognitive domain, or (2) ≥1 impaired scores (i.e. ≤16th %ile) in ≥3 cognitive domains, using demographically-corrected normative data. (1) and (2) must include the memory domain. * the primary suspected etiology of amnestic mci must be neurodegenerative, with competing differential diagnoses (e.g. psychiatric disorder, movement disorder, reversible causes, substance use) ruled out as the primary etiology/ies following a clinical evaluation by a healthcare provider. * ability to provide independent informed consent, consistent with the mci diagnostic criterion of preserved independent function. exclusion criteria: * dementia diagnosis per the diagnostic and statistical manual of mental disorders (dsm-5) or nia-aa criteria. * daily/weekly use of anticholinergics, neuroleptics, sedatives, or bupropion. stimulant use may be allowed pending investigator review. cholinesterase inhibitors, nmda receptor antagonists, and antidepressants are allowed if on a stable regimen of four weeks prior to enrollment. * history of significant or unstable condition/s that may impact cognition such as significant cardiac, cerebrovascular, or metabolic disease, severe mental illness (e.g. bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder, or other neurologic disease (e.g. severe brain injury, seizures). * mri and tms contraindications (e.g., implants, claustrophobia, conditions/treatments that lower seizure threshold, taking medications that have short half-lives, no quantifiable motor threshold, active substance use disorder, bipolar disorder). * is enrolled in a clinical trial and/or has received an investigational medication within the last 30 days.
obesity's impact on the effect of hip arthroplasty

Conditions: Hip Osteoarthritis

Summary: the purpose of this study is to investigate whether there is a correlation between hip arthroplasty patients' preoperative weight and the patients quality of life and the clinical effect one year postoperatively.


Eligibility criteria:
inclusion criteria: * all patients recommended for primary total . exclusion criteria: * rheumatoid arthritis.

Keywords: osteoarthritis obesity quality of life
clinical and microbiological outcomes of infections due to carbapenem-resistant gram-negative bacteria

Conditions: Drug Resistance, Microbial

Summary: carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with klebsiella pneumoniae, acinetobacter baumannii and pseudomonas aeruginosa . the optimal treatment of such infections is not known. antibiotics like polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics. the outcome of using these new and old drugs is not well studied. this observational study aims to study the clinical and microbiological outcomes of these infections and treatment at our institution.

objectives 1. to define the demographic and risk factor profile of patients acquiring crgnb infection. 2. to define the characteristics of crgnb infection. 3. to report the different treatments employed for crgnb infection. 4. to report the microbiological and clinical outcomes of different treatment options * a. microbiological outcomes: frequency of microbiological success. microbiological success will be defined as two successive negative cultures from the same site as from where the crgnb was originally isolated. * b. clinical outcomes: clinical success (clinical cure), adverse effects of treatment especially the nephrotoxicity in relation to the use of polymyxin, icu length of stay (if applicable), hospital length of stay, icu mortality (if applicable), hospital mortality and in-hospital recurrence of infection. clinical success will be defined as resolution or improvement of clinical symptoms and signs of infection and discontinuation of the antibiotics. study duration: we plan to collect the data for a one year period. based on the current prevalence rate at our institution, we anticipate having data for 300 patients.

Eligibility criteria:
inclusion criteria: * adult in-patients (age≥18 years) having an infection due to crgnb (klebsiella pneumoniae, acinetobacter baumannii and pseudomonas aeruginosa only). crgnb infection will be defined as isolation of crgnb from any source requiring treatment with anti-infective agents with or without manifestations of systemic inflammatory response syndrome. exclusion criteria: * patients colonized with crgnb and not having an active infection. * recurrent infection in a previously included patient.

Keywords: carbapenem klebsiella pneumoniae carbapenemase acinetobacter baumannii pseudomonas aeruginosa
prednisolone treatment in acute interstitial nephritis

Conditions: Acute Tubulo-Interstitial Nephritis

Summary: a prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis


Eligibility criteria:
inclusion criteria: * biopsy verified ain * clinical suspicion of ain * age \> 18 years * one of following criteria: * plasma creatinine \> 120 µmol/l or * plasma creatinine increase \> 30 µmol/l or increase \> 50 % of baseline plasma creatinine * fertile women are included exclusion criteria: * no ability to give informed consent * immunosuppressive treatment (including prednisolone) within 3 months before biopsy * autoimmune disease * prednisolone intolerance * pregnancy or lactation * active cancer (except basal cell carcinoma) * short life expectancy (\< 6 months) * ckd stage iv-v * ain secondary to or accompanied by glomerulonephritis, sarcoidosis or inherited interstitial renal disease * previous participation withdrawal criteria * development of exclusion criterion * withdrawal of consent

Keywords: acute tubulo-interstitial nephritis prednisone